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This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xolair | Experimental | The subcutaneous dose of Xolair administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
|
| placebo | Placebo Comparator | The subcutaneous dose of placebo administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab (Xolair) | Drug | Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Asthma Exacerbations Over the 48 Week Treatment Period | A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Asthma Symptom Scores | Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Rosen, M.D., Ph.D. | Genentech, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34303017 | Derived | Szefler SJ, Jerschow E, Yoo B, Janampally P, Pazwash H, Holweg CTJ, Hudes G. Response to Omalizumab in Black and White Patients with Allergic Asthma. J Allergy Clin Immunol Pract. 2021 Nov;9(11):4021-4028. doi: 10.1016/j.jaip.2021.07.013. Epub 2021 Jul 22. | |
| 33465457 | Derived | Chen M, Choo E, Yoo B, Raut P, Haselkorn T, Pazwash H, Holweg CTJ, Hudes G. No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities. Ann Allergy Asthma Immunol. 2021 Jun;126(6):666-673. doi: 10.1016/j.anai.2021.01.015. Epub 2021 Jan 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| FG001 | Xolair | Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All baseline measures were based on all randomized subjects who received at least one dose of study drug (the modified ITT population). The modified ITT population included 848 subjects (427 subjects in the Xolair group and 421 subjects in the placebo group). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Asthma Exacerbations Over the 48 Week Treatment Period | A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group. | Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). | Posted | Number | exacerbation/patient-week | 48 weeks |
|
48 Weeks
The safety-evaluable population, used for all safety analyses, included all randomized subjects who received at least one study drug. Subjects were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| iron deficiency anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
|
| placebo | Drug | Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab. |
|
| corticosteroids | Drug | Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day. |
|
| long-acting beta-agonists | Drug | 50 µg salmeterol twice daily or 12 µg formoterol twice daily. |
|
| Baseline and Week 48 |
| Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication | Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline. | Baseline and Week 48 |
| Change From Baseline in Overall Asthma-related Quality of Life | Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline. | Baseline and Week 48 |
| Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events | This outcome is represented in the adverse event section of the database. | Week 48 |
| 33223095 | Derived | Busse WW, Szefler SJ, Haselkorn T, Iqbal A, Ortiz B, Lanier BQ, Chipps BE. Possible Protective Effect of Omalizumab on Lung Function Decline in Patients Experiencing Asthma Exacerbations. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1201-1211. doi: 10.1016/j.jaip.2020.10.027. Epub 2020 Oct 24. |
| 33217063 | Derived | Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7. |
| 31760132 | Derived | Busse WW, Humbert M, Haselkorn T, Ortiz B, Trzaskoma BL, Stephenson P, Garcia Conde L, Kianifard F, Holgate ST. Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol. 2020 Feb;124(2):190-196. doi: 10.1016/j.anai.2019.11.016. Epub 2019 Nov 22. |
| 23471469 | Derived | Hanania NA, Wenzel S, Rosen K, Hsieh HJ, Mosesova S, Choy DF, Lal P, Arron JR, Harris JM, Busse W. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):804-11. doi: 10.1164/rccm.201208-1414OC. |
| 21536936 | Derived | Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, Rosen KE, Eisner MD, Wong DA, Busse W. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3;154(9):573-82. doi: 10.7326/0003-4819-154-9-201105030-00002. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Pregnancy |
|
| Data unknown at database lock |
|
| BG001 | Xolair | Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Xolair | Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
|
|
| Secondary | Change From Baseline in Total Asthma Symptom Scores | Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline. | Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug. Ten patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 48 |
|
|
|
| Secondary | Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication | Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline. | Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early. | Posted | Mean | Standard Deviation | puffs per day | Baseline and Week 48 |
|
|
|
| Secondary | Change From Baseline in Overall Asthma-related Quality of Life | Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline. | Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 48 |
|
|
|
| Secondary | Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events | This outcome is represented in the adverse event section of the database. | Safety Population: The safety-evaluable population comprised 848 patients (428 Xolair group and 420 placebo group). Patients in the safety-evaluable population were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study. | Posted | Number | participants | Week 48 |
|
|
|
| 44 |
| 420 |
| 339 |
| 420 |
| EG001 | Xolair | Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. | 40 | 428 | 329 | 428 |
| atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pancreatitis acute | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hiatus hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| irritable bowel syndrome | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| bile duct stenosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| anaphylactic reaction | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| lobar pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| gastroenteritis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| meningitis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| chronic sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| kidney infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| vaginal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| open wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| open fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| urinary bladder rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| facial bones fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| rib fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| forearm fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| glomus tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| amyotrophic lateral sclerosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
|
| bipolar disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| bipolar I disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| uterine enlargement | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pulmonary calcification | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
"The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |